510(k) Report

FDA applicant

Valumed

Niceville, FL2 decisions2002–20030 recalls

FDA records 2 decisions for Valumed (Niceville, FL) from 2002 to 2003: 2 510(k) clearances. Most are in product codes MMP (Cover, Barrier, Protective) and LHI (Set, I.V. Fluid Transfer). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Valumed’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Valumed since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Valumed by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MMPCover, Barrier, Protective1decision
  • LHISet, I.V. Fluid Transfer1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023540Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09Valumed · 20031cites it

What has FDA decided for it lately?

  • K023540Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09Valumed · 2003
  • K023539Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, TransflowValumed · 2002

All 2 as Valumed →